Gastrointestinal Symptoms
Conditions
Keywords
Non-inferiority Trial, Dyclonine Hydrochloride, Tetracaine Hydrochloride, Visual Analogue Scale, Topical Anesthesia, Gastroscopy
Brief summary
Gastroscopy is a key diagnostic approach for upper gastrointestinal diseases, but pharyngeal passage of the gastroscopy often causes participants' discomfort. Topical pharyngeal anesthetics are routinely used to alleviate such discomfort. Dyclonine hydrochloride mucilage and tetracaine hydrochloride jelly are the two most commonly used topical pharyngeal anesthetics in clinical practice. Although both agents are widely used, their comparative efficacy in unsedated gastroscopy remains unclear, and high-quality evidence is scarce. This study aims to compare their anesthetic efficacy,participant comfort, and safety.
Detailed description
A total of 208 participants undergoing unsedated gastroscopy will be enrolled and randomly assigned in a 1:1 ratio to either the dyclonine group or the tetracaine group. Participants in the dyclonine group will receive dyclonine hydrochloride mucilage for pharyngeal topical anesthesia, whereas those in the tetracaine group will receive tetracaine hydrochloride jelly. The primary outcome is participant comfort assessed using the Visual Analogue Scale (VAS, range 0-10) during the gastroscopy. Secondary outcomes include antifoaming efficacy, the incidence of nausea and vomiting, the duration of gastroscopy, participant and endoscopist satisfaction, and the incidence of adverse events.
Interventions
Dyclonine hydrochloride mucilage (10 ml: 0.1 g) will be used. Each participant will hold 10 ml of the solution in the throat for 2 minutes before swallowing, 10-15 minutes prior to gastroscopy.
DRUGTetracaine Hydrochloride Jelly
Tetracaine hydrochloride jelly (specification: 10 g : 0.1 g) will be administered 10-15 minutes prior to gastroscopy. A nurse will spray the jelly onto the root of the participant's tongue and then instruct the participant to swallow it.
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years, of either sex; * Scheduled for an unsedated gastroscopy; * American Society of Anesthesiologists (ASA) physical status class I or II; * Able to understand and cooperate with Visual Analogue Scale (VAS) comfort assessment; * Willing to provide written informed consent voluntarily.
Exclusion criteria
* Known allergy to the study agents; * Severe cardiopulmonary disease or hepatic/renal insufficiency; * Long-term use of sedatives or analgesics, or history of alcohol abuse; * Pregnancy or lactation; * Dysphagia or trismus (limited mouth opening); * Contraindications to upper gastrointestinal endoscopy, including acute perforation and active massive bleeding; * Mental or cognitive disorders that may preclude cooperation with the procedure; * Scheduled for therapeutic endoscopic procedures with an anticipated procedure time exceeding 15 minutes; * Altered upper gastrointestinal anatomy due to prior total gastrectomy, esophagectomy, or subtotal gastrectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale(VAS) Score | Within 5 minutes after completion of gastroscopy | Using a 0-10 Visual Analogue Scale (VAS), ranging from 0 (no discomfort) to 10 (worst possible discomfort), higher scores indicate worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported palatability acceptability | Within 1-2 minutes of buccal or spray administration | Palatability acceptability was rated on a 3-level scale ( good, moderate, poor). |
| Incidence of nausea and vomiting | Throughout the procedure and within 30 minutes after completion of gastroscopy | — |
| First-pass success rate | Throughout the intubation process | — |
| Antifoaming efficacy | Time of gastroscopy insertion into the gastric body | Assessed by the endoscopist using a 4-point grading scale: no bubbles or foam, view is clear; few bubbles present, but without interfering with mucosal evaluation; moderate amount of bubbles and foam, causing some difficulty in evaluation; abundant foam and bubbles, making mucosal evaluation hardly possible. |
| Duration of gastroscopy | Procedure time from endoscope insertion to withdrawal | — |
| Satisfaction of participant and endoscopist | Within 5 minutes after completion of gastroscopy | Satisfaction is assessed using a 5-point Likert scale, ranging from very dissatisfied to very satisfied. |
| Willingness to repeat gastroscopy (yes/no) | Within 5 minutes after completion of gastroscopy | — |
| Procedure-related pain score (VAS, 0-10) | Throughout the entire gastroscopy procedure | Using a 0-10 Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), higher scores indicate more severe pain. |
| Pharyngeal numbness after gastroscopy | Within 5 minutes after completion of gastroscopy | — |
| Swallowing function (assessed by salivary swallowing difficulty) after gastroscopy | Within 5 minutes after completion of gastroscopy | Assessed by a 4-point grading scale: normal swallowing, no difficulty; mild difficulty, foreign body sensation but does not affect swallowing; moderate difficulty, obvious effort or mild choking; severe difficulty, unable to swallow saliva normally. |
| Incidence of adverse events | Throughout the procedure and within 30 minutes after completion of gastroscopy | Incidence of dizziness, headache, choking/coughing. |
Countries
China
Contacts
CONTACTXingshun Qi
CONTACTHaoran Jia
Outcome results
None listed